Thirst in Intensive Care Unit (ICU) PracticeTHIRSTNCT05473351
Thirst in the Intensive Care Unit, Recognition, Sensitivity and Type
An observational study of Thirst in Intensive Care Unit (ICU) Practice, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Thirst is a perception that provokes the desire to drink liquids. It is a multidimensional symptom that is described in terms of intensity and distress and is associated with dry mouth, called xerostomia. Thirst is poorly recognized in intensive care unit practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thirst in Intensive Care Unit (ICU) Practice
- What is being tested?
- Questionnaire
- How many people
- 203 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Dec 2022to 29 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on invasive mechanical ventilation, admitted to one of the participating centers
Who may be able to join
- Patient 18 years of age and older
- Patients undergoing invasive mechanical ventilation for at least 24 hours at one of the participating centers
- No objection to participation in the study
Who cannot join
- Patients unable to communicate verbally and reliably self-report thirst:
- Richmond Agitation-Sedation Scale (RASS) < -2 or > +2,
- delirium according to the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) (if confusion is suspected)
- severe cognitive impairment or severe mental illness
- non-French speaking patients
- severe hearing loss.
Show all 9Show fewer
- Pregnant women
- Adults under legal protection
- Not affiliated to a social security system or not benefiting from such a system
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de médecine intensive et réanimation, hôpital Avicenne
Bobigny, 93000
Service de médecine intensive et réanimation, hôpital Saint-Louis
Paris, 75010
Service de medecine intensive et réanimation, hôpital Pitié Salpêtrière
Paris, 75013
About this study
Thirst is a perception that provokes the desire to drink liquids. It is a multidimensional symptom that is described in terms of intensity and distress and is associated with dry mouth, called xerostomia.
Thirst is poorly recognized in intensive care unit practice. Yet, research has shown that it is one of the most prevalent, most intense, and least well treated symptoms in intensive care patients. Thirst and dry mouth are associated with physical discomfort in the ICU. However, thirst often goes unnoticed and untreated.
Read more
In this context, The investigators aim to conduct a prospective observational study in mechanically ventilated patients able to communicate to better understand the prevalence, intensity, mechanisms and prognostic value of thirst as well as dry mouth sensation.
Primary objective: to assess thirst in mechanically ventilated patients. Primary endpoint: visual analog thirst scale from 0 mm (no thirst) to 100 mm (maximal thirst)
- Patient 18 years of age and older
- Patients undergoing invasive mechanical ventilation for at least 24 hours at one of the participating centers
- No objection to participation in the study During the study period, patients from 3 resuscitation sites are systematically screened for inclusion in the study on a daily basis, between 9:00 am and 12:00 pm.
Subjects meeting the inclusion and non-inclusion criteria (with the exception of the delirium test) will be informed of the study by the principal investigator or any other investigator trained and declared in the research. The oral information will be completed by the delivery of an information note. Patients who wish to participate in the study will be given up to 24 hours to consider their decision.
If the patient agrees to participate in the study, his or her non-opposition is collected by the investigator on a dedicated form in duplicate. One copy will be given to the patient, and the other will be kept in the department with the research documents.
In case of suspected confusion, a delirium screening test (CAM-ICU) will be performed to verify the patient's eligibility. If the test confirms the presence of confusion, the patient will be excluded from the study.
The information and the collection of the non-opposition will be notified in the patient's medical file.
Following their inclusion, patients are assessed only once during their stay in the ICU: the day of inclusion.
Once enrolled, patients are asked to rate the intensity of thirst by placing a cursor on a 100 mm visual analog scale (VAS) bounded on the left by "not thirsty" and on the right by "intolerably thirsty".
If a patient understands the principle of the assessment but is unable to move the VAS cursor himself, the observer assists the patient by holding the scale and supporting the patient's forearm. If the subject is unable to move his or her arms (as in some cases of severe neuromuscular impairment), observers are allowed to manipulate the VAS slider following the patient's instructions. However, this is not recommended and should be avoided whenever possible. The slider should never be adjusted directly or solely by the investigator.
The visual analog scales for dry mouth, anxiety, pain and dyspnea will be performed as part of the protocol after the thirst assessment.
The oral status, the search for edema or skin folds and the Revised Oral Assessment Guide (ROAG) score for intubated patients will also be performed at the same time.
An average of 20 minutes is necessary to perform all these procedures.
Read the detailed description
Thirst was reported in 70% of symptom assessments of intensive care patients. Thirst is a major source of physical discomfort. This should make it a concern for clinicians and ICU nurses whose mission is to alleviate symptoms in addition to treating pathology.
Balancing extracellular and intracellular volume is a goal in the poorly communicating patient with no spontaneous access to water. Thirst may exist, persist, reappear, or increase again after the institution of water intake; it may reveal changes in the intra/extra sector or inappropriate intakes. Thirst could therefore be useful as a clinical management tool. However, it has not been studied to any great extent in mechanically ventilated patients.
Neglecting thirst in these circumstances is bound to cause suffering. This neglect may also offset the physiological benefits in terms of clinical outcomes. It could also have a negative impact at a distance through negative memories. Nevertheless, thirst is not routinely assessed in ICU patients, except after extubation when the patient has access to spontaneous hydration.
Mechanically ventilated patients have multiple causes of thirst and dry mouth and at the same time have difficulty communicating and limited access to water. It is essential to study thirst in this population. In particular, determining the prevalence of thirst in this population would raise awareness of its screening. Finally, understanding the main mechanisms involved in thirst in patients undergoing invasive mechanical ventilation would allow the development of therapeutic solutions to minimize it.
In this context, the investigators wish to conduct a prospective observational study in mechanically ventilated patients able to communicate in order to better understand the prevalence, intensity, mechanisms and prognostic value of thirst as well as the sensation of dry mouth. They will also focus on the relationship of thirst with dyspnea, anxiety and pain.
Description of the study population and rationale for its selection The management of thirst is usually ensured by free access to water and balancing the patient's extracellular volume.
In the mechanically ventilated patient, this management is made more difficult by many factors: lack of free access to water, difficulty in communication, sensation of dry mouth induced by the mechanical ventilation device.
The population studied corresponds to patients under invasive mechanical ventilation in three intensive care units of university hospitals:
Pitié Salpêtrière intensive care medicine unit, Avicenne hospital intensive care medicine unit, and Saint-Louis hospital intensive care medicine unit.
Justification of the duration of the research The objective would be to include 200 patients at a rate of approximately 66 patients per service.
Eligibility criteria Recruitment will consist in considering any patient under mechanical ventilation and communicating as potentially eligible, provided that they meet the inclusion/non-inclusion criteria.
Conduct of the research During the study period, patients from the 3 resuscitation sites are systematically screened for inclusion in the study on a daily basis, between 9:00 am and 12:00 pm.
Subjects meeting the inclusion and non-inclusion criteria will be informed of the study by the principal investigator or any other investigator trained and declared in the research. The oral information will be supplemented by an information note. Patients who wish to participate in the study will be given up to 24 hours to consider their decision.
If the patient agrees to participate in the study, his or her non-opposition is collected by the investigator on a dedicated form in duplicate. One copy will be given to the patient, and the other will be kept in the department with the research documents.
In case of suspected confusion, a delirium screening test (CAM-ICU) will be performed to verify the patient's eligibility. If the test confirms the presence of confusion, the patient will be excluded from the study.
The information and the collection of the non-opposition will be notified in the patient's medical file.
Once recruited, patients are asked to rate the intensity of thirst by placing a cursor on a 100 mm visual analog scale (VAS) bounded on the left by "not thirsty" and on the right by "intolerably thirsty".
If a patient understands the principle of the assessment but is unable to move the VAS cursor himself, the observer assists the patient by holding the scale and supporting the patient's forearm. If the subject is unable to move his or her arms (as in some cases of severe neuromuscular impairment), the observers are allowed to manipulate the VAS slider by following the patient's instructions. However, this is not recommended and should be avoided whenever possible. The slider should never be adjusted directly or solely by the investigator.
Visual analog scales for dry mouth, anxiety, pain, and dyspnea will be performed as part of the protocol after the thirst assessment. The oral status, the search for edema or skin folds and the Revised Oral Assessment Guide (ROAG) score for intubated patients will also be performed at the same time.
Follow-up of the population The included patients are evaluated only once during their stay in the ICU: the day of inclusion. The duration of their participation is estimated at 20 minutes.
Conduct in the presence of thirst in the patient In the event that the patient is thirsty, the investigator will immediately inform the patient's physician.
- Being tested
- Questionnaire
- Keywords
- Thirst, Intensive care unit,, Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Visual Analogic Scale
| Study group | Role | What they receive |
|---|---|---|
| Thirst | Patients undergoing invasive mechanical ventilation for at least 24 hours in one of the participating centers Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
:Assessment of thirst in mechanically ventilated patients.
visual analog thirst scale from 0 mm (no thirst) to 100 mm (maximum thirst)
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Evaluation of the association between thirst and dry mouth in mechanically ventilated patients.
Visual analog scale of dry mouth
Measured: Through study completion, an average of 1 year
Evaluation of the association between thirst and oral status in mechanically ventilated patients.
Oral status: Oral Health Assessment Tool
Measured: Through study completion, an average of 1 year
valuation of the association between thirst and extracellular volume in ventilated patients
Physical examination oriented towards the evaluation of extracellular and intracellular volume: presence of edema of the lower limbs or lumbar region, presence of a skin fold
Measured: Through study completion, an average of 1 year
Evaluation of the association between thirst and anxiety in the mechanically ventilated patient.
Visual Anxiety Scale
Measured: Through study completion, an average of 1 year
Evaluation of the association between thirst and pain in mechanically ventilated patients.
Visual Analogue Pain Scale measures pain intensity. It consists of a 10 numerical values, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: Through study completion, an average of 1 year
Evaluation of the association between thirst and dyspnea in mechanically ventilated patients.ventilated patients.
Visual analog scale of dyspnea measures dyspnea severity. It consists of a 10 numerical values, with two end points representing 0 ('absence of dyspnea') and 10 ('maximum dyspnea')
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start29 Dec 2022
- Primary completion29 Oct 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thirst in Intensive Care Unit (ICU) PracticeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473351
- Sponsor's protocol ID
- APHP220789
- Acronym
- THIRST
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2022
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thirst in the Intensive Care Unit, Recognition, Sensitivity and Type
- ClinicalTrials.gov ID
- NCT05473351
- Acronym / sponsor ID
- THIRST / APHP220789
- Keywords
- Thirst, Intensive care unit,, Cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thirst is a perception that provokes the desire to drink liquids. It is a multidimensional symptom that is described in terms of intensity and distress and is associated with dry mouth, called xerostomia.
Thirst is poorly recognized in intensive care unit practice. Yet, research has shown that it is one of the most prevalent, most intense, and least well treated symptoms in intensive care patients. Thirst and dry mouth are associated with physical discomfort in the ICU. However, thirst often goes unnoticed and untreated.
In this context, The investigators aim to conduct a prospective observational study in mechanically ventilated patients able to communicate to better understand the prevalence, intensity, mechanisms and prognostic value of thirst as well as dry mouth sensation.
Primary objective: to assess thirst in mechanically ventilated patients. Primary endpoint: visual analog thirst scale from 0 mm (no thirst) to 100 mm (maximal thirst)
- Patient 18 years of age and older
- Patients undergoing invasive mechanical ventilation for at least 24 hours at one of the participating centers
- No objection to participation in the study During the study period, patients from 3 resuscitation sites are systematically screened for inclusion in the study on a daily basis, between 9:00 am and 12:00 pm.
Subjects meeting the inclusion and non-inclusion criteria (with the exception of the delirium test) will be informed of the study by the principal investigator or any other investigator trained and declared in the research. The oral information will be completed by the delivery of an information note. Patients who wish to participate in the study will be given up to 24 hours to consider their decision.
If the patient agrees to participate in the study, his or her non-opposition is collected by the investigator on a dedicated form in duplicate. One copy will be given to the patient, and the other will be kept in the department with the research documents.
In case of suspected confusion, a delirium screening test (CAM-ICU) will be performed to verify the patient's eligibility. If the test confirms the presence of confusion, the patient will be excluded from the study.
The information and the collection of the non-opposition will be notified in the patient's medical file.
Following their inclusion, patients are assessed only once during their stay in the ICU: the day of inclusion.
Once enrolled, patients are asked to rate the intensity of thirst by placing a cursor on a 100 mm visual analog scale (VAS) bounded on the left by "not thirsty" and on the right by "intolerably thirsty".
If a patient understands the principle of the assessment but is unable to move the VAS cursor himself, the observer assists the patient by holding the scale and supporting the patient's forearm. If the subject is unable to move his or her arms (as in some cases of severe neuromuscular impairment), observers are allowed to manipulate the VAS slider following the patient's instructions. However, this is not recommended and should be avoided whenever possible. The slider should never be adjusted directly or solely by the investigator.
The visual analog scales for dry mouth, anxiety, pain and dyspnea will be performed as part of the protocol after the thirst assessment.
The oral status, the search for edema or skin folds and the Revised Oral Assessment Guide (ROAG) score for intubated patients will also be performed at the same time.
An average of 20 minutes is necessary to perform all these procedures.
Detailed description
Thirst was reported in 70% of symptom assessments of intensive care patients. Thirst is a major source of physical discomfort. This should make it a concern for clinicians and ICU nurses whose mission is to alleviate symptoms in addition to treating pathology.
Balancing extracellular and intracellular volume is a goal in the poorly communicating patient with no spontaneous access to water. Thirst may exist, persist, reappear, or increase again after the institution of water intake; it may reveal changes in the intra/extra sector or inappropriate intakes. Thirst could therefore be useful as a clinical management tool. However, it has not been studied to any great extent in mechanically ventilated patients.
Neglecting thirst in these circumstances is bound to cause suffering. This neglect may also offset the physiological benefits in terms of clinical outcomes. It could also have a negative impact at a distance through negative memories. Nevertheless, thirst is not routinely assessed in ICU patients, except after extubation when the patient has access to spontaneous hydration.
Mechanically ventilated patients have multiple causes of thirst and dry mouth and at the same time have difficulty communicating and limited access to water. It is essential to study thirst in this population. In particular, determining the prevalence of thirst in this population would raise awareness of its screening. Finally, understanding the main mechanisms involved in thirst in patients undergoing invasive mechanical ventilation would allow the development of therapeutic solutions to minimize it.
In this context, the investigators wish to conduct a prospective observational study in mechanically ventilated patients able to communicate in order to better understand the prevalence, intensity, mechanisms and prognostic value of thirst as well as the sensation of dry mouth. They will also focus on the relationship of thirst with dyspnea, anxiety and pain.
Description of the study population and rationale for its selection The management of thirst is usually ensured by free access to water and balancing the patient's extracellular volume.
In the mechanically ventilated patient, this management is made more difficult by many factors: lack of free access to water, difficulty in communication, sensation of dry mouth induced by the mechanical ventilation device.
The population studied corresponds to patients under invasive mechanical ventilation in three intensive care units of university hospitals:
Pitié Salpêtrière intensive care medicine unit, Avicenne hospital intensive care medicine unit, and Saint-Louis hospital intensive care medicine unit.
Justification of the duration of the research The objective would be to include 200 patients at a rate of approximately 66 patients per service.
Eligibility criteria Recruitment will consist in considering any patient under mechanical ventilation and communicating as potentially eligible, provided that they meet the inclusion/non-inclusion criteria.
Conduct of the research During the study period, patients from the 3 resuscitation sites are systematically screened for inclusion in the study on a daily basis, between 9:00 am and 12:00 pm.
Subjects meeting the inclusion and non-inclusion criteria will be informed of the study by the principal investigator or any other investigator trained and declared in the research. The oral information will be supplemented by an information note. Patients who wish to participate in the study will be given up to 24 hours to consider their decision.
If the patient agrees to participate in the study, his or her non-opposition is collected by the investigator on a dedicated form in duplicate. One copy will be given to the patient, and the other will be kept in the department with the research documents.
In case of suspected confusion, a delirium screening test (CAM-ICU) will be performed to verify the patient's eligibility. If the test confirms the presence of confusion, the patient will be excluded from the study.
The information and the collection of the non-opposition will be notified in the patient's medical file.
Once recruited, patients are asked to rate the intensity of thirst by placing a cursor on a 100 mm visual analog scale (VAS) bounded on the left by "not thirsty" and on the right by "intolerably thirsty".
If a patient understands the principle of the assessment but is unable to move the VAS cursor himself, the observer assists the patient by holding the scale and supporting the patient's forearm. If the subject is unable to move his or her arms (as in some cases of severe neuromuscular impairment), the observers are allowed to manipulate the VAS slider by following the patient's instructions. However, this is not recommended and should be avoided whenever possible. The slider should never be adjusted directly or solely by the investigator.
Visual analog scales for dry mouth, anxiety, pain, and dyspnea will be performed as part of the protocol after the thirst assessment. The oral status, the search for edema or skin folds and the Revised Oral Assessment Guide (ROAG) score for intubated patients will also be performed at the same time.
Follow-up of the population The included patients are evaluated only once during their stay in the ICU: the day of inclusion. The duration of their participation is estimated at 20 minutes.
Conduct in the presence of thirst in the patient In the event that the patient is thirsty, the investigator will immediately inform the patient's physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thirst | – | Other: QuestionnairePatients undergoing invasive mechanical ventilation for at least 24 hours in one of the participating centers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on invasive mechanical ventilation, admitted to one of the participating centers
Key inclusion criteria (3 listed)
- Patient 18 years of age and older
- Patients undergoing invasive mechanical ventilation for at least 24 hours at one of the participating centers
- No objection to participation in the study
Key exclusion criteria (9 listed)
- Patients unable to communicate verbally and reliably self-report thirst:
- Pregnant women
- Adults under legal protection
- Not affiliated to a social security system or not benefiting from such a system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireVisual Analogic Scale | Other | Thirst |
Primary outcome
:Assessment of thirst in mechanically ventilated patients.
Time frame: Through study completion, an average of 1 year
visual analog thirst scale from 0 mm (no thirst) to 100 mm (maximum thirst)
6 secondary outcomes
Evaluation of the association between thirst and dry mouth in mechanically ventilated patients.
Time frame: Through study completion, an average of 1 year
Evaluation of the association between thirst and oral status in mechanically ventilated patients.
Time frame: Through study completion, an average of 1 year
valuation of the association between thirst and extracellular volume in ventilated patients
Time frame: Through study completion, an average of 1 year
Evaluation of the association between thirst and anxiety in the mechanically ventilated patient.
Time frame: Through study completion, an average of 1 year
Evaluation of the association between thirst and pain in mechanically ventilated patients.
Time frame: Through study completion, an average of 1 year
Evaluation of the association between thirst and dyspnea in mechanically ventilated patients.ventilated patients.
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Related trials for Thirst in Intensive Care Unit (ICU) Practice
Enrolling by invitation
Thirst Translation and RCT
Thirst in Intensive Care Unit (ICU) Practice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thirst in Intensive Care Unit (ICU) Practice, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
:Assessment of thirst in mechanically ventilated patients. (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.